Clinical Trials Progress
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TransCon CNP (navepegritide): Topline data from the pivotal ApproaCH Trial is expected in the coming weeks. If successful, Ascendis plans to submit a New Drug Application to the FDA for children with achondroplasia (age 2-11 years) in the first quarter of 2025. The company also plans to complete enrollment in the combination TransCon hGH and TransCon CNP COACH trial during the third quarter of 2024, with topline Week 26 data expected in the second quarter of 2025. Additionally, Ascendis expects to initiate teACH, a Phase 2 trial in adolescents with achondroplasia, in the fourth quarter of 2024.
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Oncology Programs: Ascendis presented new and updated results from the ongoing Phase 1/2 IL-Believe Trial of TransCon IL-2 β/γ at ASCO 2024. Initial results from the Phase 2 dose expansion cohort of the IL-Believe Trial, focusing on TransCon IL-2 β/γ in combination with chemotherapy in platinum-resistant ovarian cancer, will be presented at the European Society for Medical Oncology (ESMO) 2024 Congress.
Financial Update and Outlook
- As of June 30, 2024, Ascendis Pharma had cash, cash equivalents, and marketable securities totaling €259 million, a decrease from €399 million as of December 31, 2023.
- Full year 2024 SKYTROFA revenue is expected to be between €220 million to €240 million.
- Total operating expenses (SG&A and R&D) for 2024 are expected to be approximately €600 million.
- Ascendis expects to be operating cash flow breakeven on a quarterly basis in 2024 or 2025, pending the launch timing of YORVIPATH in the U.S.
Second Quarter 2024 Financial Results
- Total revenue for the second quarter of 2024 was €36.0 million, compared to €47.4 million during the same period in 2023.
- Research and development (R&D) costs for the second quarter of 2024 were €83.5 million, down from €105.0 million in the same period in 2023.
- Selling, general, and administrative (SG&A) expenses for the second quarter of 2024 were €74.3 million, up from €70.3 million in the same period in 2023.
- Net finance income for the second quarter of 2024 was €29.4 million, compared to €26.4 million during the same period in 2023.
- Ascendis Pharma reported a net loss of €109.4 million, or €1.91 per share (basic and diluted) for the second quarter of 2024, compared to a net loss of €121.4 million, or €2.16 per share (basic and diluted) for the same period in 2023.
Conference Call and Webcast
Ascendis Pharma will host a conference call and webcast to discuss its second quarter 2024 financial results. The live webcast and teleconference registration details are available on the Ascendis Pharma website.
